Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT01721902
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Patients with ischemic heart disease manifested by Canadian class II or greater angina and/or New York Heart Association class II, III or IV exercise intolerance AND who have undergone diagnostic coronary angiography demonstrating at least 70% diameter narrowing of at least 2 major coronary arteries or branches or at least 50% diameter narrowing of the left main coronary artery.
* Left ventricular systolic dysfunction evaluated by echocardiography or LV angiography (LV ejection fraction less than or equal to 49%).
* No contraindications or exclusions (see below)
* Willingness to participate and ability to provide informed consent
Exclusion Criteria:
* Contraindications to magnetic resonance imaging .
* Need for emergent revascularization.
* Need for concomitant surgical procedure at the time of CABG (e.g. valve repair or replacement, aneurysm resection, etc.).
* Hemodynamically unstable patients.
* Patients with confirmed transmural myocardial infarction within 4 weeks, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes.
* Prior CABG surgery.
* Stroke within 1 month prior to planned CABG.
* Diagnosed with human immunodeficiency virus (HIV) or any other immune disorder or immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.)
* Organ dysfunction
* Contra-indication for bone marrow aspiration (Thrombocytopenia \< 50.000 mm3, INR \> 2.0, use of antiplatelet agents other than aspirin).
* Hemoglobin less than 8g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3
* Active infection
* Myelodysplastic syndrome (MDS)
* Significant cognitive impairment
* Any condition associated with a life expectancy of less than 6 months
* Patients known allergic reaction or contraindication to any of the component of the CD133+ enriched cells
* Participation in other studies concomitant with this study
* History of severe ventricular tachy-arrythmias
* Inability or unwillingness to provide written informed consent
* Positive serum pregnancy test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01721902
Study Brief:
Protocol Section:
NCT01721902